Biogen Licensing Deal is Sweet Music for Bolstering MS Portfolio

Biogen_John Tlumacki/The Boston Globe via Getty

John Tlumacki/The Boston Globe via Getty

Biogen is bolstering its multiple sclerosis (MS) pipeline through a licensing agreement with Maine-based MedRhythms for its investigational digital therapeutic MR-004, which is being assessed for the potential treatment of gait deficits in MS.

This morning, Biogen said the partnership combines its leadership and global footprint in MS with MedRhythms’ digital expertise. The companies believe the development of MR-004 will address significant unmet patient needs by potentially providing MS patients with improved independence related to mobility. If it passes through the clinic and wins regulatory approval, MR-004 could become the first prescription digital therapeutic for gait deficit in MS. The investigational digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS), Biogen said.

MedRhythms is conducting two ongoing feasibility studies for MR-004. The company said it will initiate a registrational trial in the near future based on the readout from the first study.

MS is a disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell. The cause of multiple sclerosis is not known and there is no cure for the debilitating disease. It is estimated that about 2.3 million people globally live with the disease, with hundreds of thousands more who remain undiagnosed. Biogen has been a leader in multiple sclerosis for many years, with prescription drugs for different forms of the disease, including Tysabri, Tecfidera and Plegridy.

Martin Dubuc, head of digital health at Biogen, said MR-004 has the potential to be an innovative treatment option for MS patients that could address walking impairment, which is a common issue that impacts the overall quality of life for those patients. Dubuc said Biogen is harnessing the potential of digital therapeutics, which showcases the company’s ongoing commitment to advancing novel therapies for MS patients.

“At MedRhythms, we are committed to redefining what is possible for people living with neurologic diseases by building evidence-based products that meaningfully impact symptoms that have been underserved by traditional treatment modalities,” Brian Harris, chief executive officer of MedRhythms said in a statement. “We look forward to what our collaboration with Biogen, a global leader in MS, could mean for the patients we serve around the world.”

The deal is backend-heavy for MedRhythms. Under terms of the licensing deal, MedRhythms will receive $3 million in an upfront payment and will be eligible to receive up to $117.5 million in potential milestone payments. The company will also be eligible to receive tiered royalties in the high-single digits to low-teens on potential global sales.

For Boston-based Biogen, the partnership with MedRhythms comes at a time the company is at a crossroads as it prepares for a shift in leadership. Earlier this week, the company announced that Chief Executive Officer Michel Vounatsos, who has guided the company since 2017, will leave his position. A hunt is on for a new CEO.

His departure was preceded by other notable changes at the C-suite level, including the departure of Alfred Sandrock, the former head of R&D at Biogen who is now the CEO of Voyager Therapeutics, as well as the departure of Johanna Rossell, who served as the global commercial lead for Alzheimer’s at Biogen, left the company to join Enzyvant.

Not only is Biogen’s leadership at a crossroads, but the company also continues to reel from the U.S. Centers for Medicare and Medicaid’s decision to limit coverage of Aduhelm to patients who are participating in clinical trials. Because of that limitation, as well as the difficulty the Alzheimer’s drug has had getting off the ground since its controversial approval, the company announced earlier this week that it would substantially eliminate its commercial infrastructure supporting Aduhelm. Biogen said it will retain minimal resources to manage patient access programs for the medication, including a free drug program for patients currently receiving treatment. The company will continue to finance some regulatory and R&D-related activities.

Back to news